United States Patent 10,751,349: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,751,349, issued on August 25, 2020, is a significant patent in the pharmaceutical sector, particularly related to obeticholic acid formulations. This patent is assigned to Intercept Pharmaceuticals, Inc. and covers various aspects of obeticholic acid, including its formulations, preparation methods, and uses.
Background on Obeticholic Acid
Obeticholic acid, marketed under the brand name Ocaliva, is a medication used primarily for the treatment of primary biliary cholangitis (PBC) and other liver diseases. The drug has been the subject of several patents, each focusing on different aspects of its formulation, synthesis, and application[2].
Patent Overview
Inventors and Assignee
The patent was invented by a team of researchers including Richard Gail Lancaster, Kay K. Olmstead, Masashi Kagihiro, Mitsuhiro Matono, Ikuko Taoka, Mark Pruzanski, David Shapiro, Roya Hooshmand-Rad, Richard Pencek, Cathi Sciacca, Lise Eliot, Jeffrey Edwards, Leigh A. MacConell, and Tonya K. Marmon. The assignee is Intercept Pharmaceuticals, Inc.[2].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are crucial as they delineate what is protected under the patent.
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Claim 1: This claim describes compositions of obeticholic acid with improved stability, dissolution, and/or solubility. It specifies the formulation and the methods for preparing these compositions[5].
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Claim 12: This claim focuses on the methods of treating various diseases and conditions using the obeticholic acid formulations described in the patent[5].
Dependent Claims
Dependent claims build upon the independent claims and provide additional details or limitations. For example, claim 14 of a related patent (’337 Patent) explicitly refers to the use of jet-milling in the preparation of obeticholic acid, which is not mentioned in the independent claim 11 of the same patent[1].
Definitions and Terminology
Key Terms
- Obeticholic Acid Form 1: Defined as non-crystalline obeticholic acid, which is a key component in several of the patent claims[1].
- Substantially Pure Solid Form: Refers to a solid form of obeticholic acid with a potency of greater than about 95%, taking into account impurities such as solvents and water[1].
- Particles: Has its plain and ordinary meaning, which is “minute portions of matter”[1].
Patent Landscape
Related Patents
The patent landscape for obeticholic acid includes several other patents issued to Intercept Pharmaceuticals, Inc. These patents cover various aspects such as:
- Patent 10,047,117: Issued on August 14, 2018, focusing on the preparation and uses of obeticholic acid[2].
- Patent 10,052,337: Issued on August 21, 2018, covering compositions of obeticholic acid with improved stability, dissolution, and/or solubility[2].
- Patent 10,174,073: Issued on January 8, 2019, also related to the preparation and uses of obeticholic acid[2].
- Patent 10,758,549: Issued on September 1, 2020, similar to Patent 10,751,349, focusing on compositions and methods of use for obeticholic acid[2].
Patent Expiration Dates
The patent expiration dates for these related patents vary but generally fall between 2033 and 2036. For example:
- Patent 10,751,349: Expires on April 26, 2036[2].
- Patent 10,047,117: Expires on September 6, 2033[2].
Significance and Impact
Therapeutic Uses
The patent covers the use of obeticholic acid in treating various diseases and conditions, particularly primary biliary cholangitis (PBC) and other liver diseases. The improved formulations enhance the stability, dissolution, and solubility of the drug, making it more effective and easier to administer[5].
Market and Competition
As of the current date, there is no therapeutically equivalent generic version of Ocaliva available in the United States. This gives Intercept Pharmaceuticals, Inc. a significant market advantage until the patent expires[2].
Legal and Regulatory Aspects
Patent Litigation and Disputes
The interpretation of patent claims can be a subject of litigation. For instance, the court ruling on disputed claim terms in related patents emphasized the importance of claim differentiation and the plain and ordinary meaning of terms like "particles" and "substantially pure solid form"[1].
Patent Scope and Quality
The scope and quality of patent claims are critical. Narrower claims are often associated with a higher probability of grant and a shorter examination process. The examination process tends to narrow the scope of patent claims, ensuring clarity and validity[3].
Expert Insights and Statistics
Industry Experts
Industry experts emphasize the importance of clear and specific patent claims to avoid litigation and ensure innovation. For example, a Federal Trade Commission (FTC) report highlighted concerns over broad and unclear claims in software and internet patents, which can impede innovation[3].
Statistics
- The patent examination process tends to narrow the scope of claims, with longer examination durations resulting in more significant scope reductions[3].
- The number of forward citations and patent maintenance payments can be used as metrics to measure the scope and quality of patents[3].
Conclusion and Future Outlook
The United States Patent 10,751,349 is a pivotal patent in the field of pharmaceuticals, particularly for the treatment of liver diseases. Its scope and claims are carefully defined to protect the proprietary formulations and methods of obeticholic acid. As the patent landscape evolves, it is crucial for Intercept Pharmaceuticals, Inc. and other stakeholders to monitor the expiration dates and potential generic entries into the market.
Key Takeaways
- Patent Scope: The patent covers compositions of obeticholic acid with improved stability, dissolution, and/or solubility.
- Claims: Independent claims define the core of the invention, while dependent claims provide additional details.
- Related Patents: Several other patents issued to Intercept Pharmaceuticals, Inc. cover related aspects of obeticholic acid.
- Expiration Dates: The patent expires on April 26, 2036.
- Market Impact: No generic version of Ocaliva is currently available, giving Intercept Pharmaceuticals, Inc. a market advantage.
- Legal Aspects: Clear and specific claims are essential to avoid litigation and ensure patent validity.
Frequently Asked Questions (FAQs)
Q: What is the primary use of obeticholic acid covered under Patent 10,751,349?
A: The primary use is the treatment of various diseases and conditions, particularly primary biliary cholangitis (PBC) and other liver diseases.
Q: Who is the assignee of Patent 10,751,349?
A: The assignee is Intercept Pharmaceuticals, Inc.
Q: What is the expiration date of Patent 10,751,349?
A: The patent expires on April 26, 2036.
Q: Are there any generic versions of Ocaliva available in the United States?
A: No, there are currently no therapeutically equivalent generic versions of Ocaliva available in the United States.
Q: How does the patent landscape impact the market for obeticholic acid?
A: The absence of generic versions and the exclusive rights granted by the patent give Intercept Pharmaceuticals, Inc. a significant market advantage until the patent expires.
Cited Sources:
- District of Delaware. 20-1105.pdf. March 4, 2022.
- Drugs.com. Generic Ocaliva Availability. November 6, 2024.
- Hoover Institution. Patent Claims and Patent Scope. August 18, 2024.
- Google APIs. United States Patent. January 15, 2019.
- Unified Patents. US-10751349-B2. August 25, 2020.
